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Shenzhen Kangtai Begins Phase I Clinical Trial for 20-Valent Pneumococcal Vaccine
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China-based Shenzhen Kangtai Biological Products Co., Ltd (SHE: 300601) has announced the enrollment of the first patient in the Phase I study for its 20-valent pneumococcal polysaccharide conjugate vaccine. This vaccine is designed to prevent infectious diseases caused by 20 pneumococcal serotypes, targeting infants and children aged between 2 months…
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Sichuan Kelun-Biotech Receives NMPA Clearance for SKB501 Clinical Trial in Solid Tumors
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Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has announced that it has received clearance from the National Medical Products Administration (NMPA) in China for a clinical trial filing of its pipeline candidate, SKB501. The novel antibody drug conjugate (ADC) is now set to be assessed in the treatment of advanced…
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Lepu Medical Technology Gains NMPA Approval for Obesity and Diabetes Treatments MWN109 and MWN105
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China-based Lepu Medical Technology (Beijing) Co., Ltd (SHE: 300003), a leading provider of cardiovascular disease solutions, has announced that it has received clinical approvals from the National Medical Products Administration (NMPA) for its innovative therapies, MWN109 and MWN105. Both treatments are indicated for overweight or obesity and type 2 diabetes,…
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Merck’s Winrevair Shows Positive Results in Phase III ZENITH Study for PAH
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US-based pharmaceutical giant Merck & Co., Inc. (NYSE: MRK) has announced favorable interim analysis results from the pivotal Phase III ZENITH study for its drug Winrevair (sotatercept-csrk), an activin signaling inhibitor. The study’s success marks a significant milestone in the treatment of pulmonary arterial hypertension (PAH). ZENITH Study Design and…
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GeneQuantum Healthcare’s GQ1011 (AMB302) Receives FDA Approval for Clinical Study
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China-based GeneQuantum Healthcare, a leading developer of antibody drug conjugates (ADCs), has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a clinical study for GQ1011 (AMB302). This FGFR3-targeted ADC was co-developed with South Korea-based biotech Aimed Bio under an agreement established in…
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Henlius Biotech Initiates Phase III Study for HLX22 in Gastric Cancer Treatment
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Shanghai Henlius Biotech Co., Ltd (HKG: 2696) has announced the dosing of the first patient in a global, multi-center Phase III study for its drug candidate HLX22. The study will compare the combination of HLX22 with trastuzumab and chemotherapy against the same regimen with or without pembrolizumab in the first-line…
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MicroPort Scientific Corp.’s BonaFire Receives NMPA Approval as First Whole-Body MRI Safety Pacing Electrode Lead
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Shanghai-based medical device giant MicroPort Scientific Corp. (HKG: 0853) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its whole-body magnetic resonance imaging (MRI) condition safety pacing electrode lead, BonaFire. This marks a significant milestone, as BonaFire becomes the first product of its…
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Base Therapeutics’ NK510 Receives US FDA Clearance for Advanced Solid Tumor Studies
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Shanghai-based cell therapy specialist Base Therapeutics has achieved clearance from the US Food and Drug Administration (FDA) to study its NK510 in advanced solid tumors, following clinical approval in China last month. This development marks a significant step forward for the company’s base-edited universal NK cell therapy. NK510: A Leap…
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GSK’s Arexvy Receives MHLW Approval for Expanded RSV Indication in Japan
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UK-based pharmaceutical company GlaxoSmithKline (GSK; NYSE: GSK) has announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved an expansion of the indication for Arexvy to include adults aged 50-59 who are at an increased risk of respiratory syncytial virus (RSV) infection. This marks a significant step in…
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China Resources Double-Crane Gets NMPA Approval for Semaglutide Biosimilar Clinical Trial
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China Resources Double-Crane Pharmaceutical Co., Ltd (SHA: 600062) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its biosimilar version of Denmark-based Novo Nordisk’s (NYSE: NVO) weight loss drug semaglutide, which is marketed as Ozempic and Wegovy. The product is set to…
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J&J Submits sBLA to FDA for Subcutaneous Tremfya Regimen in Ulcerative Colitis
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Johnson & Johnson (J&J; NYSE: JNJ) has submitted a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) for a subcutaneous (SC) induction regimen of Tremfya (guselkumab). The application is based on results from the Phase III ASTRO study and seeks approval for the drug to…
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Servier’s Vorasidenib Approved in Boao Lecheng Medical Zone for Diffuse Gliomas
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French pharmaceutical company Servier’s Voranigo (vorasidenib), an isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor, has been granted approval for use in the Boao Lecheng medical tourism pilot zone as a clinically urgently needed import drug. This approval comes in response to the pressing clinical needs for treatments targeting diffuse…
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Leads Biolabs’ LBL-024 Earns FDA Orphan Drug Designation for Neuroendocrine Cancer
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China-based Leads Biolabs Inc. has announced that it has obtained Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for its anti-PD-L1/4-1BB bispecific antibody, LBL-024. This designation is for the treatment of neuroendocrine cancer, a rare and aggressive form of cancer. Mechanism of Action and Preclinical EfficacyLBL-024…
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Signet Therapeutics’ SIGX1094 Earns Orphan Drug Designation for Gastric Cancer from FDA
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China-based Signet Therapeutics has announced that it has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for its FAK-targeted drug, SIGX1094, which is being developed to treat gastric cancer. This designation highlights the potential impact of SIGX1094 in addressing a significant unmet medical need. SIGX1094:…
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MSD Partners with Cancer Foundation of China for HPV Vaccine Donation Program
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has entered into a donation agreement with the Cancer Foundation of China (CFC) to support a cervical cancer prevention and control program. Under this agreement, MSD will donate a total of 81,000 doses of the human papillomavirus (HPV) vaccine to the CFC. The…
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Sciwind Biosciences’ Ecnoglutide Accepted for Review by China’s NMPA for Type 2 Diabetes
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China-based Sciwind Biosciences Co., Ltd has announced that the National Medical Products Administration (NMPA) has accepted its market filing for the Category 1 product ecnoglutide. The targeted indication for this treatment is blood glucose control in adult patients with type 2 diabetes. Ecnoglutide’s Therapeutic Potential and Clinical Trial SuccessEcnoglutide is…
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HutchMed Anticipates Milestone Payment as Takeda Launches Fruzaqla in Japan for CRC
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China-based HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) is poised to receive a milestone payment from its partner Takeda (TYO: 4502), following the successful pricing approval and launch of Fruzaqla (fruquintinib) 1mg/5mg capsules in Japan. The drug is indicated for patients with previously treated metastatic colorectal cancer (CRC). Fruzaqla’s Approval…
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First Patient Dosed in Abbisko’s Phase II Trial of ABSK061 and ABSK043 in FGFR2/3 Altered Tumors
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Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced the first patient dosing in an open, multi-center Phase II study. The study is designed to assess the safety and efficacy of its investigational drugs ABSK061 combined with ABSK043, with or without chemotherapy, in patients with metastatic or unresectable solid…
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Bayer’s Nubeqa Files for FDA Approval in mHSPC
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German pharmaceutical company Bayer AG (ETR: BAYN) has announced that the US Food and Drug Administration (FDA) has accepted its supplemental new drug application (sNDA) for Nubeqa (darolutamide) for review. Bayer is seeking approval for its androgen receptor inhibitor (ARi) in combination with androgen deprivation therapy (ADT) for the treatment…
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China Grants Marketing Approval for MSD’s Welireg for von Hippel-Lindau Disease Tumors
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China’s National Medical Products Administration has issued marketing approval for Merck, Sharp & Dohme’s (MSD; NYSE: MRK) oral drug Welireg (belzutifan) as a therapy for von Hippel-Lindau (VHL) disease-related renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastoma, and pancreatic neuroendocrine tumor (pNET) that do not require immediate surgical intervention.…
